BIOCON PHARMA LIMITED

Biocon's Q2FY25 consolidated revenue was Rs. 3,623 crore with a net loss of Rs. 16 crore. Biosimilars grew 19%, driven by US oncology and insulins. Syngene returned to growth, while generics faced price and demand pressures. Biocon Biologics refinanced $1.1 billion debt, oversubscribed 3x, reflecting investor confidence.

Federal Circuit denies Regeneron's request for injunction pending appeal against Amgen's biosimilar aflibercept launch, expediting the case for January 2025 oral arguments.

Gautam Shah discusses new age tech stocks, focusing on Zomato, Nazara, and Cartrade.

Kiran Mazumdar-Shaw, Biocon's Executive Chairperson, awarded Honorary Doctor of Science by Concordia University for her leadership in biotechnology and affordable healthcare.

Dong-A ST received FDA approval for Imuldosa, a Stelara biosimilar, amidst a crowded market of approved but unlaunched biosimilars. Stelara's sales are expected to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva set to launch in 2025. Stelara, an IL-12/IL-23 inhibitor, treats psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.

India is a leading hub for biologics and biosimilars, with over the past decade seeing the largest number of approved biosimilars serving global patients. The government’s 2012 and 2016 guidelines have facilitated increased investment and established a regulatory framework for biosimilars, ensuring quality, safety, and efficacy. The loss of exclusivity for several patented biotech drugs in the U.S. has driven market growth, with accelerated biosimilar adoption in major markets. Leading domestic firms like Dr. Reddy’s are expanding their biologics facilities and product pipelines, with some products already commercialized globally.

India's bioeconomy, valued at $151 billion in 2023, contributes 4.25% to GDP and is projected to reach $300 billion by 2030. Dominated by BioPharma, BioAgri, BioIndustrial, BioResearch, and BioIT sectors, it benefits from biotech innovation, bio-manufacturing, and COVID-19 R&D investments. India aims to be a top global bio-manufacturing hub and achieve a $1 trillion bioeconomy by 2047.

FDA approved Fresenius Kabi and Formycon's Otulfi™ (ustekinumab-aauz) as the fourth biosimilar of Janssen/Johnson & Johnson’s Stelara® (ustekinumab) on September 27, 2024, following Amgen’s Wezlana™, Alvotech/Teva’s Selarsdi™, and Samsung Bioepis/Sandoz’s Pyzchiva®. Otulfi™ received EU approval on the same day. Under settlement agreements, Otulfi™, Wezlana™, Selarsdi™, and Pyzchiva® can enter the U.S. market by February 2025. Numerous Stelara® biosimilars await FDA approval, with no pending patent disputes.